Advanced CAPA & Root Cause Analysis Conference

 

About Conference

CAPA is the most critical and challenging quality system requirement in terms of complex thinking and organizational processes. How do you verify effectiveness? How can you apply project management to CAPA? What are the right data and tools for identifying trends? How do you deal with significant but infrequent problems? Should you set deadlines for closing CAPAs, and what about CAPAs that never close? What are best practices for documenting and communicating CAPA results? Not a CAPA 101 course, this workshop brings together leading industry CAPA process owners to discuss approaches to the most difficult problems in CAPA and root cause analysis. 


Speakers:

  • Scott Blood – VP, Quality Assurance & Regulatory Affairs, Solace Therapeutics
  • Angel Iglesias – Senior Quality System Manager, Boston Scientific
  • Denise Nazario – Senior Manager, Quality Systems, Global CAPA Manager, Stryker
  • Blaine Spangler - Senior Manager Quality, CAPA Process Owner, Baxter International
  • Jon Speer – Founder & VP QA/RA, greenlight.guru
  • Other speakers to be announced

 

What you will learn:

  • Applying project management to CAPA : methods and key performance indicators
  • Tools and techniques for root cause analysis
  • Distinguishing systemic root cause from technical root cause
  • The right data sources and strategies for attacking difficult problems
  • A risk-based approach to CAPA
  • “Pressure tests” and verification of CAPA effectiveness
  • CAPA deadlines and aging CAPAs
  • The relationship between CAPA and other quality functions – using CAPA as a tool for improvement

 

Attendees are invited to submit their challenges for panel discussions

  • When

  • Wednesday, January 23, 2019 - Thursday, January 24, 2019
    8:30 AM - 4:00 PM
    Eastern Time

  • Where

  • Hogan Lovells
    Washington, District of Columbia 20004
    USA

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